FDA 483 - Central Admixture Pharmacy Services, Inc. - February 22, 2013

The FDA Form 483 details multiple deficiencies observed during an inspection. The firm failed to thoroughly review batch failures and investigate quality deficiency trends in a timely manner. Specifically, recurring leaks in sterile injectable Total Parenteral Nutrition (TPN) bags, known since February 2010, were not investigated until August 2012, despite 22 complaints at this facility between February 2012 and February 2013. The firm also did not fully evaluate its own process for checking TPN bags for leaks. Additionally, three batches of Sodium Citrate 40% Solution failed potency specifications since February 2012, yet no investigation into this trend was initiated.

Aseptic processing areas exhibited deficiencies in environmental monitoring. Air, surface, glove fingertip bioburden, and air particulate matter sampling in ISO-5 zones were performed on a periodic basis instead of daily. Personnel clothing in ISO-7 cleanrooms was deemed inappropriate, with exposed skin on the forehead, around the eyes, and on the neck, as hoods and goggles were not used, and hairnets, beard covers, and face masks were non-sterile.

Component handling and storage were inadequate, as a bag of Citric Acid, a component for sterile injectable drugs, was observed with a hole exposing its contents to unclassified air in the warehouse. Furthermore, air pressure differentials in aseptic processing areas were not continuously monitored during sterile injectable drug production. Finally, procedures to prevent